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2023.02.15
Active substance: atovaquone/proguanil hydrochloride | celecoxib | eprosartan | pregabalin | saquinavir
No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India. The risk assessment procedure for medicinal products based on studies by this company is therefore no longer relevant for medicinal products authorised in Germany.
The Federal Institute for Drugs and Medical Devices (BfArM) has extended the suspension of the marketing authorisations, which were based on studies by the company Semler Research Center (SRC) in India, by decision of 04.05.2022.
The Federal Institute for Drugs and Medical Devices (BfArM) has provisionally ordered the suspension of further generic drug approvals based on studies by the company Semler Research Center (SRC) in India.
In a notice dated 8 August 2016, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled a provisional suspension of the marketing authorisations of several generic medicinal products.
Details on the procedure can be found on the website of the European Medicines Agency (EMA):
To the risk assessment procedure (available in German only)